QUALANGIO: Study of Clinical, Biological Characteristics and Quality of Life of Patients With Hereditary or Acquired Non Drug-induced Bradykinin-mediated Angioedema, Monitored in Besançon's Partner Site Reference Center for Studies of Kinin-mediated Angioedema (CREAK)

• Sponsor: Centre Hospitalier Universitaire de Besancon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03240991
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Actual Duration (Months): 4.7
• Patients Per Site Per Month: 9.6

Study Details

Study Description

Brief Summary

This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires

Condition or Disease	Intervention/Treatment	Phase
Angioedema	Other: Quality of life

Study Design

• Study Type: Observational
• Actual Enrollment: 45 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Actual Study Start Date: Jul 11, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Quality of life questionnaires Data will be collected retrospectively and prospectively.	Other: Quality of life; Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score

Outcome Measures

Primary Outcome Measures

1. Dermatology Life Quality Index (DLQI) [6 months]

   Description of Quality of Life (QoL) using DLQI

2. Angioedema Quality of Life (AE-QoL) Questionnaire [6 months]

   Description of QoL using AE-QOL questionnnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinically documented angioedema due to C1 inhibitor deficiency, hereditary (type I et

1. or acquired

• Clinically documented angioedema with normal C1 inhibitor activity (hereditary type III)

Exclusion Criteria:

• Acquired angioedema with normal C1 inhibitor activity (former "drug-induced")

• Minor subjects

• Vulnerable subjects (under guardianship/curatorship/tutorship)

• Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Besançon	Besançon		France	25000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT03240991
• Other Study ID Numbers: P/2016/302
• First Posted: Aug 7, 2017
• Last Update Posted: Apr 17, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Centre Hospitalier Universitaire de Besancon: bradykinin-mediated angiodema; quality of life
• Additional relevant MeSH terms: Angioedema

Study Results

No Results Posted as of Apr 17, 2018